510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K871664 | Iron & Magnesium Additions/referril B Calibrator | Instrumentation Laboratory Co. | JIX | Class II | |
| K871618 | Prefilled Sterile Water for Inhalation, Usp | Automatic Liquid Packaging, Inc. | BTT | Class II | |
| K871608 | Rodriguez Nail | Richards Medical Co., Inc. | HSB | Class II | |
| K871524 | Dahlberg Model Uh in-the-Ear Hearing Aid | Dahlberg Electronics, Inc. | ESD | Class I | |
| K871509 | Resubmitted Triglyceride Gpo Reagent (Single Vial) | Trace Scientific, Ltd. | CDT | Class I | |
| K871508 | Resubmitted Triglyceride Gpo - Two Vial | Trace Scientific, Ltd. | CDT | Class I | |
| K871502 | Personnel Protective Shield | Cis-Us, Inc. | KPY | Class I | |
| K871495 | Bandages Catalog Number: 101 to 220 | I M, Inc. | NAD | Class I | |
| K871486 | (Fpia) Assay Buffer | Windsor Laboratories, Inc. | JJF | Class I | |
| K871293 | Servo Nebulizer 945 Siemens-Elema Ab | Siemens Elema AB | CAF | Class II | |
| K871214 | Graticule | Mick Radio-Nuclear Instruments, Inc. | IYE | Class II | |
| K871189 | Sunbeam Dura-Vap Warm Steam Vaporizer Model 1380 | Sunbeam Appliance Service Co. | KFZ | Class I | |
| K871046 | Compass Stereotactic Positioning System | Stereotactic Medical Systems, Inc. | HAW | Class II | |
| K870867 | Km-4(Tm) Metal-Backed Acetabular Cup | Kirschner Medical Corp. | JDL | Class III | |
| K870863 | Fna Thyroid Biopsy Kit | Flint Laboratories Div. Travenol | FMI | Class II | |
| K870602 | Imagen Herpes Simplex Virus (Hsv) Typing Test | Boots-Celltech Diagnostics, Inc. | GQN | Class II | |
| K870513 | Csi/3d | Columbia Scientific, Inc. | JAK | Class II | |
| K870470 | Trach Mate Tracheal Tube | Mccormick Laboratories, Inc. | BTR | Class II | |
| K870432 | A1-A2 Ambulatory EEG Cassette Recorder | Grass-Telefactor Product Group | GWQ | Class II | |
| K870387 | Euromedical, Endosoft Endotracheal Tube | American Pharmaseal Div. Ahsc | BTR | Class II | |
| K871595 | Surgical Camera Accessories | M.P. Video, Inc. | KQM | Class I | |
| K871478 | Surgical Packs, Surgical Kits and Surgical Trays | Procedure Pak, Inc. | FSM | Class I | |
| K871448 | Model 105 Ventilator | Developmed Corp. | CBK | Class II | |
| K871440 | Kratz Nova-Sert | CooperVision, Inc. | KYB | Class I | |
| K871398 | Cpu-1 Intensive Care Ventilator | GE Healthcare | CBK | Class II | |
| K871377 | Namic Cournand Style Introducer Needle | North American Instrument Corp. | DRC | Class II | |
| K871375 | Site Peristaltic Module System | Site Microsurgical Systems, Inc. | HQE | Class II | |
| K871264 | Cariescreen Lb | Apo Diagnostics, Inc. | JSJ | Class I | |
| K871245 | Laser Contact Lenses Cga 1, Cgi 1, Cgp 1, Cgv 1 | Chiron Vision Corp. | LQJ | Class II | |
| K870759 | Cleaning Solution, Catalog No. 8203 | Treace Medical, Inc. | LRJ | Class I | |
| K870718 | American Alcohol Prep Pad Sterile Medium | Span-America Medical Systems, Inc. | LKB | Unclassified | |
| K870276 | Heated Instrument Bath | Simpson/Basye, Inc. | LRJ | Class I | |
| K870187 | Norfolk Norport, Subcut. Implanted Drug Del. Depot | Norfolk Medical Products, Inc. | LJT | Class II | |
| K864575 | Mingograf 740 - Model #91-54-634 | Siemens Medical Solutions USA, Inc. | LOS | ||
| K871629 | Folding Litter Support, Nsn6530-00-660-0034 | Junkin Safety Appliance Co., Inc. | FPP | Class I | |
| K871582 | Patient Mover(tm) | T.B.S., Inc. | ILK | Class II | |
| K871537 | Cantrol Hdl Cholestrol Controls Levels I and II | Canyon Diagnostics, Inc. | JJY | Class I | |
| K871504 | Disposable Periodontal Probe | Periodontal Health Brush, Inc. | EIX | Class I | |
| K871494 | Uppercycle Stationary Exercise Machines | Engineering Dynamics Corp. | ISD | Class II | |
| K871438 | Bandage, Muslin, Compressed, Camouflaged 37X37x52 | Fraass Survival Systems, Inc. | EFQ | Unclassified | |
| K871391 | Amigo-A288310 (Scooter, Commuter Cart, 3-Wheeled) | Amigo Sales, Inc. | INF | Class I | |
| K871382 | Namic One Part Introducer Needle | North American Instrument Corp. | DRC | Class II | |
| K871378 | Namic Seldinger Introducer Needle | North American Instrument Corp. | DRC | Class II | |
| K871333 | Implantable Tined, Trans. Pacing Lead/revis. Label | Medtronic, Inc. | DTB | Class III | |
| K871196 | Rheuma-Check Enzyme Immunoassay Test | Orion Diagnostica, Inc. | DHR | Class II | |
| K871112 | Peltiertherapy(c) Heat/cold Treatment | Henley Intl. | IMF | Class I | |
| K871055 | Precimat(r) Crp | Boehringer Mannheim Corp. | DCK | Class II | |
| K871009 | Mvp-1500 Continuous Ventilator | Medimex, Inc. | CBK | Class II | |
| K870981 | Model 8700 Bipolar Electrosurgical Generator | Everest Medical Corp. | GEI | Class II | |
| K870976 | Onguard 1000, Catalog #043611-000 & 043611-001 | Cobe Laboratories, Inc. | DTQ | Class II |